Last updated on May 2019

A Safety Study of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant


Brief description of study

This post authorization safety study is designed as prospective non interventional study for patients with newly diagnosed multiple myeloma who are not eligible for transplant. The objective is to compare the incidence of cardiovascular events between patients treated with a first-line lenalidomide containing regimen and those treated with a first-line non-lenalidomide containing regimen. Treatment in both cohorts will be done according to standard care. The study will gather risk factor information at baseline and throughout follow-up. Any cardiovascular event occurring will be assessed by an independent committee. Other safety endpoints will be collected through standard procedures. Observation period will be 3 years on treatment, with an additional evaluation of cardiovascular events 6 months' post treatment and a follow up period until 5 years after inclusion. During follow up the incidence of second primary malignancies (SPM) and overall survival will be assessed.

Clinical Study Identifier: NCT03106324

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CHU Saint-Pierre

Bruxelles, Belgium
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CHU-Charleroi

Bruxelles, Belgium
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CHU-Charleroi

Charleroi, Belgium
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UZ Gent

Gent, Belgium
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AZ Groeninge

Kortijk, Belgium
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AZ Nikolaas

Sint Niklass, Belgium
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CHPLT Verviers

Verviers, Belgium
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CH Victor Dupouy

Argenteuil, France
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CH Mont de Marsan

Mont de Marsan, France
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Stauferklinikum

Mutlangen, Germany
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Das Diak

Schwabisch Hall, Germany
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Kliniken Villingen-Schwenningen

Villingen-Schwenningen, Germany
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Rode Kruis Hospital

Beverwijk, Netherlands
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Nij Smellinghe

Drachten, Netherlands
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R pcke-Zweers Hospital

Hardenberg, Netherlands
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Isala Hospital

Zwolle, Netherlands
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Son Espases

Palma de Mallorca, Spain
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Recruitment Status: Open


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